Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer
RATIONALE: Hormone therapy may be an effective treatment for prostate cancer.
PURPOSE: Randomized phase III trial to evaluate the effectiveness of treatment with flutamide and suramin with or without hydrocortisone in men who have metastatic or recurrent prostate cancer.
|Prostate Cancer||Drug: flutamide Drug: goserelin acetate Drug: leuprolide acetate Drug: suramin Drug: therapeutic hydrocortisone Procedure: orchiectomy||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER|
|Study Start Date:||October 1996|
|Primary Completion Date:||April 1998 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Compare time to progression and survival in patients with metastatic or recurrent adenocarcinoma of the prostate treated with orchiectomy or LHRH analogue (i.e. leuprolide or goserelin) plus flutamide with vs. without suramin and hydrocortisone. II. Compare these two treatments with respect to qualitative and quantitative toxic effects. III. Evaluate normalization of prostatic-specific antigen (PSA), duration of PSA response, and the use of PSA as a surrogate marker of tumor response in these patients. IV. Compare these two treatments with respect to quality of life and pain status.
OUTLINE: This is a randomized study. Patients are stratified by their choice of androgen suppression technique and by participating institution. Within 3 days after randomization, all patients receive daily flutamide. On day 4, patients undergo orchiectomy or begin monthly LHRH analogue therapy with leuprolide or goserelin. Patients randomized to receive suramin begin a 12-week course 8-25 days after orchiectomy/LHRH therapy. Hydrocortisone replacement therapy begins concomitantly with suramin and continues for at least 3 months after the completion of suramin treatment or until disease progression intervenes. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 800-1,000 patients will be entered within 3.25 to 4.25 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002881
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307-5000|
|Study Chair:||George Wilding, MD||University of Wisconsin, Madison|
|Study Chair:||Nancy A. Dawson, MD||Walter Reed Army Medical Center|
|Study Chair:||A. O. Sartor, MD||Louisiana State University Health Sciences Center in New Orleans|